Indus botanical drug for HIV/AIDS & H1N1 swine flu treatment

Non-synthetic drug got permission to conduct human trials in US; awaits DCGI’s approval to begin clinical studies in India

A non-synthetic HIV/AIDS drug derived from natural food chain botanicals developed by Indus Biotech Private Ltd has also been found effective against H1N1 swine flu virus.

The experimental HIV/AIDS drug candidate named IND02 which has been found safe and effective in pre-clinical studies and limited human studies.

Indus Biotech will soon start full-fledged human studies on the HIV/AIDS drug IND02.

Indus Biotech has already obtained investigational new drug (IND) approval from the US FDA to start human clinical trials for HIV/AIDS drug candidate IND02 in America.

Indus Bio is seeking permission through an IND submission with Drug Controller General of India (DCGI) and is awaiting its clearance to start human studies in India.

IND02 is also seen working against H1N1 swine flu, according the developer of the drug Indus Biotech.

Research conducted at one of the laboratories at the National Taiwan University Hospital in Taipei showed that IND02 is very effective against H1N1 swine flu virus.

Indus Biotech now plans to develop IND02 drug for influenza and H1N1, both as a drug as well as a prophylactic since the drug shows promise in preventing the infection.

While other drugs attack the virus directly, the Indus drug help the human body to prevent replication of the virus by strengthening the host defense factor against the HIV/AIDS or H1N1 swine flu virus infection,Indus officials have stated

Indus Biotech Private Limited follows a different approach to discovering molecules which the company claims can reduce the time and cost of hugely expensive drug discovery process at the same time avoiding expensive failures that are common with new drug development.

Indus Biotech chooses drug candidates from food chain raw materials that have existing evidence of physiological activity.

Indus Biotech has developed a proprietary platform technology for separation and isolation of molecules by molecular partitioning, wherein each drug candidate is novel and protected by IPR.

Based on rational drug design with retro pharmacology, all isolated molecules are screened in animal models for specific diseases. This method obviates the need for mass screening and reduces pre-clinical development cost.

After confirming efficacy and safety in pre-clinical stage, the drug candidates are tested for safety and efficacy in “proof-of-concept clinical trials” in humans.

Even though all molecules are derived from food chain botanicals that have a long history of human use as food, each molecule undergoes toxicology testing. The molecules are also studied for their mechanism of action and potential side effects. The subsequent development is based on evidence based randomized controlled trials (RCTs).

Indus Biotech uses this facility to conduct relevant and early “proof-of-concept” studies and thus mitigates risk of failure in the future.

The Pune-based Indus Biotech has developed several molecules in therapeutic areas including allergy, asthma, rheumatoid arthritis, inflammatory bowel disease, Parkinson’s disease, depression, Huntington’s disease, obesity and diabetes, age-related macular degeneration, kidney diseases besides HIV?AIDS and influenza which are currently at various stages of clinical development.

H1N1 swine flu pandemic has already gripped almost all the continents causing the death of over 5000 people around the globe. H1N1 swine virus could also make a second wave of attack as the flu season begins, alerted WHO.

There are over six million patients suffering from HIV in India and over 40 million globally.